ALBUTEROL SULFATE solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)

Beszerezhető a:

Mylan Pharmaceuticals Inc.

Az alkalmazás módja:

RESPIRATORY (INHALATION)

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Albuterol Sulfate Inhalation Solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease). Albuterol Sulfate Inhalation Solution is contraindicated in patients with a history of hypersensitivity to any of its components. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: The Ritedose Corporation Columbia, SC 29203 U.S.A. TRC:PIL:ASISLD:R2 RPIN0178 Revised: 8/2022

Termék összefoglaló:

Albuterol Sulfate Inhalation Solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.63 mg/3 mL and 1.25 mg/3 mL, of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of Albuterol Sulfate Inhalation Solution is available in a shelf carton containing multiple foil pouches. Albuterol Sulfate Inhalation Solution, 0.63 mg/3 mL (potency expressed as albuterol) contains 0.75 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration. NDC 0378-7057-52 5 foil pouches, each containing 5 vials, total 25 vials per carton Albuterol Sulfate Inhalation Solution, 1.25 mg/3 mL (potency expressed as albuterol) contains 1.5 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration. NDC 0378-7058-52 5 foil pouches, each containing 5 vials, total 25 vials per carton Rx only STORAGE Store between 2°C to 25°C (36°F to 77°F). Protect from light and excessive heat. Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial(s) within two weeks. Discard the vial if the solution is not colorless. Keep out of the reach of children. The brands listed are trademarks of their respective owners. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: The Ritedose Corporation Columbia, SC 29203 U.S.A. TRC:ASISLD:R2 RPIN0178 Revised: 8/2022

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Albuterol sulfate inhalation solution is a sterile, clear, colorless
solution of the sulfate salt
of racemic albuterol, albuterol sulfate. Albuterol sulfate is a
relatively selective beta -
adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical
name for
albuterol sulfate is α [(tert-butylamino)
methyl]-4-hydroxy-m-xylene-α, α’-diol sulfate
(2:1) (salt), and its established chemical structure is as follows:
The molecular weight of albuterol sulfate is 576.7 and the empirical
formula is
(C
H
NO ) • H SO . Albuterol sulfate is a white crystalline powder,
soluble in water
and slightly soluble in ethanol. The World Health Organization
recommended name for
albuterol is salbutamol.
Albuterol Sulfate Inhalation Solution is supplied in two strengths in
unit dose vials. Each
unit dose vial contains either 0.63 mg of albuterol equivalent to 0.75
mg of albuterol
sulfate or 1.25 mg of albuterol equivalent to 1.5 mg of albuterol
sulfate with sodium
chloride, edetate disodium (EDTA), and sulfuric acid in a 3-mL
isotonic, sterile, aqueous
solution. Sodium chloride is added to adjust isotonicity of the
solution, EDTA is added as
a stabilizer for the active pharmaceutical ingredient, and sulfuric
acid is added to adjust
pH of the solution to 3.5 (see HOW SUPPLIED).
Albuterol Sulfate Inhalation Solution does not require dilution prior
to administration by
nebulization. For Albuterol Sulfate Inhalation Solution, like all
other nebulized treatments,
the amount delivered to the lungs will depend on patient factors, the
jet nebulizer
utilized, and compressor performance. Using the Pari LC Plus™
nebulizer (with face
mask or mouthpiece) connected to a Pari PRONEB™ compressor, under in
vitro
conditions, the mean delivered dose from the mouth piece (% nominal
dose) was
approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol
(0.63 mg
strength) at a mean flow rate of 3.6 L/min. The mean nebulization time
was